Leg bags now in use by patients suffering from urinary incontinence are commonly equipped with inlet and outlet tubes and are designed to be strapped to a patient's leg for receiving urine directed thereto by a suitable catheter or collection tube. Because of the extended periods over which such bags are worn, it is important that contact forces be distributed as evenly as possible to avoid the development of sores, abrasions, and ulcers, and to promote greater patient comfort. Such bags should also be easy to attach, detach, and operate, be non-refluxing, non-kinking, and leak-proof in use, and be easy to connect to a sterile catheter, such as an indwelling catheter, without contaminating the flow system.
Currently-available bags are at best only partially effective at meeting these requirements. Often such bags tend to buckle in use, creating pressure points against a wearer's leg and increasing the possibilities of kinking, obstruction, backflow, disconnection, and/or rupture of the bag. Upon filling, such bags may expand in a direction away from the wearer's leg, greatly reducing the area of leg contact and increasing the force per area to create pressure points or zones. In some cases, nozzles and clamps are exposed for direct contact with the wearer's leg, not only producing discomfort but also increasing the possible development of pressure sores or ulcers. Finally, although at least some of the commercially-available bags are marketed in sterile condition with removal caps over the inlet and outlet tubes, such caps are easily dislodged and misplaced and, if prematurely removed, may expose the tubes to contamination.
A main object of this invention is to provide an improved leg bag which overcomes these shortcomings of prior bag constructions. Specifically, the bag is constructed to maximize the area of leg contact even when the bag is expanded in use, to avoid the development of pressure points or zones, to prevent direct contact between the bag's inlet and outlet tubes and the wearer's leg, to allow limited pivotal movement of such tubes, to provide a construction in which the hinged tubes tend to pivot automatically as the bag is filled to maintain positions generally parallel with the wearer's leg, thereby reducing the possibilities of kinking and flow obstruction in use and to provide a simple but highly effective means for protecting the inlet tube and, if desired, the outlet tube, against contamination, even if the sterile bag should contact a non-sterile surface or object upon removal from its wrapper.
Briefly, the bag is generally flat (when unexpanded), vertically elongated, and formed of flexible thermoplastic sheet material. Straps are provided for securing the bag to a patient's leg. Such straps are connected to upper and lower sections of the bag so that when fitted about a patient's leg they tend to urge the inner or rear wall of the bag into conforming engagement with the leg. As the bag is filled in use, side pleates formed in the outer wall of the bag expand to accommodate the fluid in a way that permits a relatively large area of the inner wall to remain in contact with the patient's leg, particularly in the portion of the bag in which the fluid is retained. The sizable area of contact promotes security and patient comfort, and reduces the possibilities that localized pressures might create irritations and produce sores.
The inlet and outlet assemblies of the bag are hingedly mounted for self-adjusting pivotal movement in use. As the bag expands, the outer wall bulges outwardly. The hinged mounting of the upper and lower tube assemblies permits those assemblies to remain parallel with the wearer's leg and to resist the angulation which such outward bulging of the bag might otherwise produce. Because the tubes are allowed to remain parallel with the leg, the possibilities of pressure point development and the chances that the flexible tube or catheter leading to the inlet tube might become kinked in use, are further reduced. U-shaped openings adjacent the inlet and outlet tubes, and transverse heat seal lines at those locations, facilitate the self-adjusting pivotal movement of the tube assemblies.
The upper and lower sections of the bag shield the wearer against direct contact with the inlet and outlet tubes, against helping to avoid the development of skin irritations and sores. Such upper and lower sections may be provided with pockets for receiving the inlet and/or outlet tubes and protecting such tubes against contamination prior to use or during storage following use.
Other features, objects, and advantages of the invention will become apparent from the specification and drawings.